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FDA 510(k)

BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR

K-Number: K033589 · 2004-10-04

ApplicantMicromedics, Inc.
Decision Date2004-10-04
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Micromedics, Inc.. It received FDA 510(k) clearance on 2004-10-04 under 510(k) number K033589. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR?

BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR is a medical device that received FDA 510(k) clearance on 2004-10-04. The listed applicant is Micromedics, Inc.. The 510(k) number is K033589.

When did BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR receive FDA 510(k) clearance?

BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR received FDA 510(k) clearance on 2004-10-04, under 510(k) number K033589.

Who is the listed applicant for BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR?

The FDA 510(k) record lists Micromedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR?

The FDA product code for BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR is FMF.

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Other records listing Micromedics, Inc. as applicant

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Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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